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Efficacy of Platelet-rich Plasma (PRP) in the Treatment of Dark Circles Under the Eyes

Primary Purpose

Periorbital Hyperpigmentation

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
PRP
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periorbital Hyperpigmentation

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with periorbital hyperpigmentation

Exclusion Criteria:

  • patients with known platelet dysfunction syndrome
  • patients with platelet count less than 100,000 ul
  • patient with hemodynamic instability
  • patients with severe systemic illness or malignancy or chronic medical illness (e.g. diabetes, chronic infections, and blood dyscrasias).
  • patients with local skin disorders or active herpes infection at the site of the procedure.
  • patients on anti-coagulants therapy or non-steroidal anti-inflammatory drugs (NSAID) within 48 hours of procedure,
  • patients with corticosteroid injection at treatment site within 1 month, systemic use of corticosteroids within 2 weeks
  • patients with recent fever or illness, and hemoglobin level< 10 g/dl.
  • pregnancy
  • history of keloidal scarring.

Sites / Locations

  • Department of Dermatology and Venereology at Damascus University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRP injection

Arm Description

A PRP-injection will be performed three times during the course of treatment

Outcomes

Primary Outcome Measures

Change in Skin Color
Standardized digital photographs will be taken and a color scale will be used

Secondary Outcome Measures

Satisfaction
Patients' satisfaction will be measured on a visual analog scale (VAS)

Full Information

First Posted
April 11, 2017
Last Updated
May 13, 2017
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT03114514
Brief Title
Efficacy of Platelet-rich Plasma (PRP) in the Treatment of Dark Circles Under the Eyes
Official Title
Efficacy of Platelet-Rich Plasma (PRP) in the Treatment of Periorbital Hyperpigmentation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 17, 2016 (Actual)
Primary Completion Date
April 20, 2017 (Actual)
Study Completion Date
May 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
10 ml of blood from each patient will be drawn. This blood specimen will be centrifuged in a specific way to get 1 ml of platelet rich plasma (PRP). PRP will be injected into the the skin under the eyes. The treatment course consists of three sessions of PRP injections with one-month intervals between the sessions.
Detailed Description
Background: Dark circles around the eyes is a common problem pretending with relatively dark eyelids concerns many patients, especially women, because of the inconvenience caused by esthetic and negative impact on the psyche and the patient's quality of life. There are several causing factors (such as sun exposure, smoking, alcohol, sleep deprivation, genetic and structural factors). variety of treatments have been used for this situation , but without clear results. The term 'Platelet-Rich Plasma (PRP)' is a general term used to describe hanging plasma that has been obtained from whole blood with concentration of platelets higher than normal concentration found in the circulating blood. PRP's work mechanism depends on the fact that platelets contain important substances called (growth factors), which have a known role in the process of reform and renewal of tissues. Aim of the research: This study was designed to evaluate the effectiveness of (PRP) injection in the treatment of dark circles under the eyes. This is an uncontrolled open therapeutic trial study which will be performed at the Hospital of Dermatology and Venereology of Damascus University in Damascus, Syria during the period from June 2016 to June 2017. The results will be assessed by standardized digital photography month after each injection and three months after the latest assessment with the assistant of skin colors scale. In addition, the patient's satisfaction with the results and any treatment-related side effects will be recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periorbital Hyperpigmentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP injection
Arm Type
Experimental
Arm Description
A PRP-injection will be performed three times during the course of treatment
Intervention Type
Biological
Intervention Name(s)
PRP
Other Intervention Name(s)
platelet-rich plasma
Intervention Description
PRP will be injected subcutaneously around the eyes at three different time points with one-month interval
Primary Outcome Measure Information:
Title
Change in Skin Color
Description
Standardized digital photographs will be taken and a color scale will be used
Time Frame
Color shade will be measured at one month following the first injection (T1) and at three months following the third injection (T2)
Secondary Outcome Measure Information:
Title
Satisfaction
Description
Patients' satisfaction will be measured on a visual analog scale (VAS)
Time Frame
Satisfaction will be measured at three months following the last injection.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with periorbital hyperpigmentation Exclusion Criteria: patients with known platelet dysfunction syndrome patients with platelet count less than 100,000 ul patient with hemodynamic instability patients with severe systemic illness or malignancy or chronic medical illness (e.g. diabetes, chronic infections, and blood dyscrasias). patients with local skin disorders or active herpes infection at the site of the procedure. patients on anti-coagulants therapy or non-steroidal anti-inflammatory drugs (NSAID) within 48 hours of procedure, patients with corticosteroid injection at treatment site within 1 month, systemic use of corticosteroids within 2 weeks patients with recent fever or illness, and hemoglobin level< 10 g/dl. pregnancy history of keloidal scarring.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raed Sameer Noueihed, M.D.
Organizational Affiliation
Resident at the Dermatology and venereology Hospital of Damascus university.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology and Venereology at Damascus University
City
Damascus
ZIP/Postal Code
DM20AM18
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17760701
Citation
Freitag FM, Cestari TF. What causes dark circles under the eyes? J Cosmet Dermatol. 2007 Sep;6(3):211-5. doi: 10.1111/j.1473-2165.2007.00324.x.
Results Reference
background
PubMed Identifier
24700933
Citation
Sheth PB, Shah HA, Dave JN. Periorbital hyperpigmentation: a study of its prevalence, common causative factors and its association with personal habits and other disorders. Indian J Dermatol. 2014 Mar;59(2):151-7. doi: 10.4103/0019-5154.127675.
Results Reference
background
PubMed Identifier
19469797
Citation
Roh MR, Chung KY. Infraorbital dark circles: definition, causes, and treatment options. Dermatol Surg. 2009 Aug;35(8):1163-71. doi: 10.1111/j.1524-4725.2009.01213.x. Epub 2009 May 15.
Results Reference
background
PubMed Identifier
19187989
Citation
Dohan Ehrenfest DM, Rasmusson L, Albrektsson T. Classification of platelet concentrates: from pure platelet-rich plasma (P-PRP) to leucocyte- and platelet-rich fibrin (L-PRF). Trends Biotechnol. 2009 Mar;27(3):158-67. doi: 10.1016/j.tibtech.2008.11.009. Epub 2009 Jan 31.
Results Reference
background
PubMed Identifier
22647081
Citation
Alsousou J, Ali A, Willett K, Harrison P. The role of platelet-rich plasma in tissue regeneration. Platelets. 2013;24(3):173-82. doi: 10.3109/09537104.2012.684730. Epub 2012 May 30.
Results Reference
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PubMed Identifier
23238115
Citation
Sommeling CE, Heyneman A, Hoeksema H, Verbelen J, Stillaert FB, Monstrey S. The use of platelet-rich plasma in plastic surgery: a systematic review. J Plast Reconstr Aesthet Surg. 2013 Mar;66(3):301-11. doi: 10.1016/j.bjps.2012.11.009. Epub 2012 Dec 11.
Results Reference
background
PubMed Identifier
27904271
Citation
Abuaf OK, Yildiz H, Baloglu H, Bilgili ME, Simsek HA, Dogan B. Histologic Evidence of New Collagen Formulation Using Platelet Rich Plasma in Skin Rejuvenation: A Prospective Controlled Clinical Study. Ann Dermatol. 2016 Dec;28(6):718-724. doi: 10.5021/ad.2016.28.6.718. Epub 2016 Nov 23.
Results Reference
background
PubMed Identifier
24795093
Citation
Conde Montero E, Fernandez Santos ME, Suarez Fernandez R. Platelet-rich plasma: applications in dermatology. Actas Dermosifiliogr. 2015 Mar;106(2):104-11. doi: 10.1016/j.ad.2013.12.021. Epub 2014 May 1. English, Spanish.
Results Reference
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Efficacy of Platelet-rich Plasma (PRP) in the Treatment of Dark Circles Under the Eyes

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